Abstract: The FDA issued five such letters since November 2014, the most recent being sent to StriVectin. Following those letters, the FDA has also issued a document that clarifies cosmetic versus drug claims for the consumer to highlight what cosmetic companies are able to say.

Market Intelligence

The U.S. Food and Drug Administration (FDA) is cracking down on cosmetic claims, or at least it would seem so. After not issuing a warning letter concerning cosmetic claims since 2012, the FDA issued five such letters since November 2014, the most recent being sent to StriVectin. Following those letters, the FDA also issued a document that clarifies cosmetic versus drug claims for the consumer to highlight what cosmetic companies are able to say.

In its recent letter to StriVectin, the FDA detailed the elastin-stimulating claims associated with the company's TL Advanced Tightening Neck Cream and its Potent Wrinkle Reducing Treatment. Claims relating to stimulating elastin are associated with altering the structure or function of the skin, according to the FDA, and therefore are considered drugs.

Of course, the cosmetic claims document made public on March 23, 2015, titled "Are Cosmetic Companies Promising Too Much" notes, "Some of the drug claims have included promises to increase production of collagen and elastin, resulting in skin that is more elastic and firmer, with fewer wrinkles." It adds that cosmetic companies cannot make claims associated with medical conditions such as acne, dandruff, rosacea, eczema, psoriasis or hair restoration, as these claims are drug-related. The former may be a given, but the FDA furthers that claims associated with reducing inflammation, regenerating cells, preventing facial muscle contractions, boosting activity of genes and providing similar results to surgery are also drug claims.

The FDA did note that it has been tracking claims for "several years," and adds that it issues warnings to any cosmetic company that makes drug-related claims. With the Sunscreen Innovation Act passed and UV filters review looming, one would assume that the FDA would not have time to tackle other issues in cosmetics; however, recent actions would suggest otherwise.